Otsuka Inqovi (decitabine and cedazuridine) Received the US FDA’s Approval to MDS and CMML

August 27, 2020 Auto Bot approval, Otsuka, regulatory, the US FDA 0

Shots:

  • The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine
  • Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval
  • Inqovi is a novel product orally administered hypomethylating agent approved by the US and Health Canada for the treatment of MDS and CMML

Click here ­to­ read full press release/ article | Ref: Otsuka | Image: Otsuka